TRIMBOW 172 micrograms/5 micrograms/9 micrograms PRESSURISED INHALATION SOLUTION

2. What you need to know before you use Trimbow

Do not use Trimbow

If you are allergic to beclometasone dipropionate, formoterol fumarate dihydrate and/or glycopyrronium or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Trimbow is used as a maintenance treatment for chronic obstructive pulmonary disease (COPD). Do not use this medicine to treat a sudden attack of shortness of breath or wheezing.

If your breathing gets worse

If, just after inhaling the medicine, you experience worsening of shortness of breath or wheezing (breathing with a whistling sound), stop treatment with the Trimbow inhaler and use your quick-acting "rescue" inhaler immediately. You should contact your doctor right away. Your doctor will assess your symptoms and, if necessary, may change your treatment.

See also section 4. Possible side effects.

If your COPD gets worse

If your symptoms get worse or are difficult to control (e.g. if you are using another "rescue" inhaler more often) or if your "rescue" inhaler does not improve your symptoms, go to your doctor immediately. It may be that your COPD is getting worse and your doctor may need to prescribe a different treatment for you.

Tell your doctor or pharmacist before you start using Trimbow:

• if you have any heart problems, such as angina (chest pain), a recent heart attack (myocardial infarction), heart failure, narrowing of the arteries of the heart (coronary artery disease), a heart valve disease or any other heart abnormality, or if you have a disease called hypertrophic obstructive cardiomyopathy (also known as HOCM, a disease in which the heart muscle is abnormal).

• if you have heart rhythm disorders, such as an irregular heartbeat, a fast pulse rate or palpitations or if you have been told that your electrocardiogram (ECG) is abnormal.

• if you have narrowing of the arteries (also known as arteriosclerosis), if you have high blood pressure or if you have an aneurysm (an abnormal bulge in the wall of a blood vessel).

• if you have an overactive thyroid gland.

• if you have low levels of potassium in your blood (hypokalaemia). The combination of Trimbow with certain other medicines for the lungs or medicines such as diuretics (medicines that make your body lose water, to treat heart disease or high blood pressure) may cause a marked decrease in potassium levels in your blood. Therefore, your doctor may want to check your potassium levels in your blood from time to time.

• if you have any liver or kidney disease.

• if you have diabetes. High doses of formoterol may increase blood sugar levels, so you may need some additional blood tests to check your blood sugar levels when you start using this medicine and from time to time during treatment.

• if you have a tumour of the adrenal gland (known as phaeochromocytoma).

• if you are going to be given an anaesthetic. Depending on the type of anaesthetic, it may be necessary to stop treatment with Trimbow at least 12 hours before the anaesthetic.

• if you are receiving or have received treatment for tuberculosis (TB) or if you have a chest infection.

• if you have a eye problem called narrow-angle glaucoma.

• if you have difficulty urinating.

• if you have an infection in your mouth or throat.

If you are in any of these situations, tell your doctor before you start using Trimbow.

If you have or have had any health problems or allergies or if you are unsure whether you can use Trimbow, consult your doctor or pharmacist before you start using the inhaler.

If you are already using Trimbow

If you are using Trimbow or high doses of other inhaled corticosteroids for long periods of time and you experience a stressful situation (e.g. if you are taken to hospital after an accident, have a serious injury or before an operation), you may need more medicine. In such situations, your doctor may need to increase your dose of corticosteroids to cope with the stress and may prescribe them in tablet or injection form.

Contact your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents

Do not give this medicine to children and adolescents under 18 years.

Other medicines and Trimbow

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines similar to Trimbow used for your lung disease.

Some medicines may increase the effects of Trimbow, so your doctor will monitor you closely if you are taking these medicines (including some for HIV: ritonavir, cobicistat).

Do not use this medicine with a beta-blocker medicine(used to treat certain heart problems such as angina or to lower blood pressure) unless your doctor has chosen a beta-blocker that does not affect your breathing. Beta-blockers (including beta-blockers in eye drops) may reduce the effects of formoterol or make them disappear. On the other hand, the use of other beta2 agonist medicines (which work in the same way as formoterol) may increase the effects of formoterol.

The use of Trimbow with:

• medicines to treat

• abnormal heart rhythms (quinidine, disopyramide, procainamide),
• allergic reactions (antihistamines),
• symptoms of depression or mental disorders such as monoamine oxidase inhibitors (e.g. phenelzine and isocarboxazid), tricyclic antidepressants (e.g. amitriptyline and imipramine) and phenothiazines

may cause some changes in the electrocardiogram (ECG, heart tracing). They may also increase the risk of heart rhythm disturbances (ventricular arrhythmias).

• medicines to treat Parkinson's disease (levodopa), medicines to treat an underactive thyroid gland (levothyroxine), medicines that contain oxytocin (which causes uterine contractions) and alcohol may increase the likelihood of formoterol's adverse effects on the heart.

• monoamine oxidase inhibitors (MAOIs), including medicines with similar properties such as furazolidone and procarbazine, used to treat mental disorders, may cause an increase in blood pressure.

• medicines to treat heart disease (digoxin) may cause a decrease in potassium levels in the blood. This may increase the likelihood of abnormal heart rhythms.

• other medicines used to treat chronic obstructive pulmonary disease (theophylline, aminophylline or corticosteroids) and diuretics may also cause a drop in potassium levels.

• certain anaesthetics may increase the risk of abnormal heart rhythms.

• disulfiram, a medicine used in the treatment of people with alcoholism (alcohol problems), or metronidazol, an antibiotic to treat infections in your body, may cause adverse effects (e.g. nausea, vomiting, stomach pain) due to the small amount of alcohol that Trimbow contains.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

You should only use Trimbow during pregnancy if your doctor advises you to. It is recommended to avoid the use of Trimbow during delivery due to the inhibitory effects of formoterol on uterine contractions.

You should not use Trimbow during breast-feeding. You and your doctor must decide whether to stop breast-feeding or stop the treatment, taking into account the benefit of breast-feeding for your child and the benefit of the treatment for you.

Driving and using machines

It is unlikely that Trimbow will affect your ability to drive and use machines.

Trimbow contains ethanol

Trimbow contains 8.856 mg of alcohol (ethanol) in each actuation, which is equivalent to 17.712 mg per dose of two actuations. The amount in two actuations of this medicine is equivalent to less than 1 ml of wine or beer. The small amount of alcohol in this medicine does not produce any noticeable effects.

3. How to use Trimbow

Follow the instructions for using this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist again.

The recommended dose is two inhalations in the morning and two inhalations in the evening.

Do not use more than the dose your doctor has prescribed.

You should use Trimbow every day, even when your asthma is under control.

Do not use this medicine to relieve a sudden attack of shortness of breath or wheezing.

If you think that the medicine is not working as well as usual, consult your doctor.

If you have been using another inhaler that contained beclometasone dipropionate before, consult your doctor, as the effective dose of beclometasone dipropionate in Trimbow for the treatment of COPD may be lower than that of other inhalers.

Method of administration

Trimbow is for inhalation use only.

You should inhale the medicine through your mouth, which takes the medicine directly to your lungs.

This medicine is in a pressurised container inside a plastic inhaler with a mouthpiece.

Trimbow is available in two container sizes:

• a container providing 60 doses
• a container providing 120 doses

There is a counter on the back of the inhaler, which shows how many doses are left. Each time you press the pressurised container, a dose of medicine is released and the counter decreases by one. Avoid dropping the inhaler as this may cause the counter to count down.

Checking the inhaler

Before you use the inhaler for the first time, you must check it in the following way to make sure that it is working correctly.

1. Depending on the container size that you have been prescribed, check that the dose counter reads 61 or 121
2. Remove the protective cap from the mouthpiece
3. Hold the inhaler upright with the mouthpiece at the bottom
4. Point the mouthpiece away from you and press the pressurised container firmly to release a dose
5. Check the dose counter. If you are checking the inhaler for the first time, the counter should read:

How to use the inhaler

Stand up or sit upright to do the inhalation.

IMPORTANT: do not perform steps 2 to 5 too quickly.

1. Remove the protective cap from the mouthpiece and check that the mouthpiece is clean, i.e. that there are no dust or dirt residues.
2. Breathe out slowly and deeply as much as you can to empty your lungs.
3. Hold the inhaler straight with the mouthpiece downwards and place the mouthpiece between your teeth without biting it. Then, place your lips around the mouthpiece, with your tongue flat under it.
4. Breathe in slowly and deeply through your mouth to fill your lungs with air (this should take about 4-5 seconds). Just after you start inhaling, press the top of the pressurised container firmly to release a dose.
5. Hold your breath for as long as you can and finally remove the inhaler from your mouth and breathe out slowly. Do not blow through the inhaler.
6. Check that the dose counter has counted down by one.

For the second dose, hold the inhaler upright for about half a minute and then repeat steps 2 to 5.

If some gas escapes from the top of the inhaler or from the corner of your lips, it means that Trimbow will not reach your lungs as it should. Take another dose following the instructions starting again from step 2.

After use, replace the protective cap.

To avoid a fungal infection in your mouth and throat, rinse your mouth or gargle with water without swallowing or brush your teeth after each use of the inhaler.

When to get a new inhaler

You should get a replacement when the counter shows the number 20. Stop using the inhaler when the counter shows 0, as any remaining medicine in the inhaler may not be enough to give you a full dose.

If you have weakness to grip, you may find it easier to hold the inhaler with both hands: place your two index fingers on the top of the inhaler and your two thumbs on the bottom of the inhaler.

If you find it difficult to use the inhaler at the same time as you start inhaling, you may use the AeroChamber Plus spacer device. Ask your doctor or pharmacist about this device.

It is important that you read the leaflet provided with the AeroChamber Plus spacer device and that you follow its instructions for use and cleaning carefully.

Cleaning the Trimbow inhaler

You should clean the inhaler once a week.

1. Do not remove the pressurised container from the inhaler and do not use water or other liquids to clean it.
2. Remove the protective cap from the mouthpiece by pulling it to separate it from the inhaler.
3. Clean the inside and outside of the mouthpiece and the inhaler with a clean and dry cloth or tissue.
4. Replace the mouthpiece cap.

If you use more Trimbow than you should

It is important that you take the dose as your doctor has prescribed. Do not exceed the prescribed dose without consulting your doctor first.

If you use more Trimbow than you should, the side effects described in section 4 may occur.

Tell your doctor if you have used more Trimbow than you should and if you experience any of these symptoms. Your doctor may want to do some blood tests.

If you forget to use Trimbow

Use it as soon as you remember. If it is almost time for your next dose, do not take the missed dose, but take the next dose at the correct time. Do not take a double dose.

If you stop using Trimbow

It is important to use Trimbow every day. Do not stop treatment with Trimbow or reduce the dose, even if you feel better or do not have symptoms. If you want to do this, consult your doctor.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

There is a risk of worsening breathing difficulties and wheezing immediately after using Trimbow, known as paradoxical bronchospasm (may affect up to 1 in 1,000 people). If this occurs, you should discontinue treatment with Trimbow and use your rapid-acting "rescue" inhaler without delay to treat breathing difficulties and wheezing. You should contact your doctor immediately.

Inform your doctor immediately

• if you experience allergic reactions such as skin allergies, hives, itching of the skin, skin rash (may affect up to 1 in 100 people), skin redness, skin swelling or mucous membranes, especially of the eyes, face, lips, and throat (may affect up to 1 in 1,000 people).
• if you experience pain or discomfort in the eyes, blurred vision, visual halos, or colored images associated with red eyes. These may be signs of an acute narrow-angle glaucoma attack (may affect up to 1 in 10,000 people).

Inform your doctor if you notice any of the following symptoms during the use of Trimbow, as they may be due to a lung infection (may affect up to 1 in 10 people):

• fever or chills
• increased mucus production, change in mucus color
• increased coughing or difficulty breathing

The possible adverse effectsare listed below according to their frequency.

Frequent(may affect up to 1 in 10 people)

• throat pain
• nasal secretion or congestion and sneezing
• mouth fungal infections. Rinsing the mouth or gargling with water and brushing teeth immediately after inhalation can help prevent these adverse effects
• hoarseness
• headache
• urinary tract infection

Uncommon(may affect up to 1 in 100 people)

Rare(may affect up to 1 in 1,000 people)

Very Rare(may affect up to 1 in 10,000 people)

• low level of certain blood cells called platelets
• feeling of suffocation or difficulty breathing
• swelling of the hands and feet
• growth delay in children and adolescents

Frequency Not Known(cannot be estimated from the available data)

• blurred vision

The use of inhaled corticosteroids in high doses for a prolonged period may cause, in very rare cases, effects on the body:

• problems with the functioning of the adrenal glands (adrenal suppression)
• decrease in bone mineral density (thinning of the bones)
• clouding of the eye lens (cataract)

Trimbow does not contain a high-dose inhaled corticosteroid, but your doctor may want to measure your cortisol levels in the blood from time to time.

The following adverse effects may also occur when inhaled corticosteroids are used in high doses for a prolonged period, but their frequency is currently not known (cannot be estimated from the available data):

• depression
• feeling of worry, nervousness, overexcitement, or irritability

These effects are more likely in children.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Trimbow

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date stated on the label and carton after CAD / EXP. The expiration date is the last day of the month indicated.

Do not freeze.

Do not expose to temperatures above 50 °C.

Do not puncture the pressurized container.

Before dispensing:

Store in a refrigerator (between 2 °C and 8 °C).

After dispensing (after receiving this medicine from your pharmacist):

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the containers and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Trimbow

The active ingredients are: beclometasone dipropionate, formoterol fumarate dihydrate, and glycopyrronium.

Each delivered dose (the dose that comes out of the mouthpiece) contains 172 micrograms of beclometasone dipropionate, 5 micrograms of formoterol fumarate dihydrate, and 9 micrograms of glycopyrronium (in the form of 11 micrograms of glycopyrronium bromide).

Each measured dose (the dose that comes out of the valve) contains 200 micrograms of beclometasone dipropionate, 6 micrograms of formoterol fumarate dihydrate, and 10 micrograms of glycopyrronium (in the form of 12.5 micrograms of glycopyrronium bromide).

The other ingredients are: anhydrous ethanol (see section 2), hydrochloric acid, propellant: norflurane.

This medicine contains fluorinated greenhouse gases.

Each 60-puff inhaler contains 6.471 g of norflurane (HFC-134a), which corresponds to 0.009 tons of CO2 equivalent (global warming potential GWP = 1430).

Each 120-puff inhaler contains 10.354 g of norflurane (HFC-134a), which corresponds to 0.015 tons of CO2 equivalent (global warming potential GWP = 1430).

Appearance of the Product and Package Contents

Trimbow is an inhalation solution in a pressurized container.

Trimbow is presented in a pressurized container (aluminum-coated), with a metering valve. The pressurized container is inserted into a plastic inhaler. This incorporates a mouthpiece with a plastic protective cap and a dose counter (containers with 60 and 120 doses).

Each container contains a pressurized container that provides 60 doses or 120 doses. There are also multiple containers that contain 240 doses (2 pressurized containers with 120 doses each) or 360 doses (3 pressurized containers with 120 doses each).

Only some package sizes may be marketed.

Marketing Authorization Holder

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A

43122 Parma

Italy

Manufacturer

Chiesi Farmaceutici S.p.A.

Via San Leonardo 96

43122 Parma

Italy

Chiesi SAS

2 rue des Docteurs Alberto et Paolo Chiesi

41260 La Chaussée Saint Victor

France

Chiesi Pharmaceuticals GmbH

Gonzagagasse 16/16

1010 Wien

Austria

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet: November 2024

Other Sources of Information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.